Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer
08 Dezembro 2022 - 9:30AM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a women’s oncology company developing novel treatments for
breast and gynecologic cancers, announced preliminary Phase 2 data
from the ongoing SMILE trial of onapristone extended release
(ONA-XR), the company’s novel, first-in-class, potent, orally
administered progesterone receptor (PR) antagonist, in metastatic
breast cancer.
Being conducted in collaboration with the Wisconsin Oncology
Network, the Phase 2 SMILE trial is evaluating ONA-XR in
combination with fulvestrant in patients with ER+, HER2- advanced
or metastatic breast cancer who progressed on prior CDK4/6
inhibitor therapy. Preliminary Phase 2 findings highlight a 4-month
progression free survival (PFS) rate of 44%, and favorable safety
and tolerability. The data were presented at the 2022 San Antonio
Breast Cancer Symposium® (SABCS®).
Also at SABCS, an initial look at the trial design of the
recently initiated ELONA Phase 1b/2 clinical trial evaluating the
combination of ONA-XR with The Menarini Group’s oral selective
estrogen degrader, elacestrant, in patients with second- or
third-line advanced or metastatic ER+, PR+, HER2- breast cancer was
presented. Data from the Phase 1b portion of the trial is expected
in Q4 2023.
“We are pleased to be building a robust package of data
supporting the safety and tolerability of ONA-XR and its
potentially meaningful improvement over single agent standards of
care,” said Martin Lehr, CEO of Context Therapeutics. “We’re
encouraged by the improvement in preliminary PFS observed in the
SMILE trial presented at SABCS this week, which is consistent with
the significant improvement in PFS recently reported in the ongoing
Phase 2 endometrial cancer trial. We look forward to the continued
evaluation of ONA-XR across multiple ongoing breast cancer clinical
trials, including the SMILE and ELONA trials.”
The Company also recently announced preliminary Phase 2 findings
for ONA-XR in combination with anastrozole in progesterone
receptor-positive (PR+) metastatic endometrial cancer, highlighting
a 4-month PFS rate of 77% and favorable safety and
tolerability.
“There is a clear unmet need in metastatic endometrial cancer
for a therapeutic option after primary or secondary chemotherapy
treatment that can meaningfully delay disease progression without
debilitating side effects prior to the next round of cytotoxic
therapy,” said Lehr. “We believe that dual targeting of both the
progesterone receptor and estrogen receptor at efficacious doses
without dose limiting toxicities could potentially result in a
competitive product profile for ONA-XR. It is our hope that ONA-XR
will one day address this unmet need.”
For additional clinical updates, read the Company’s third
quarter 2022 operating and financial results release.
About ONA-XRONA-XR (onapristone extended
release) is a potent and specific antagonist of the progesterone
receptor (PR) that is orally administered. Currently, there are no
approved therapies that selectively target PR+ cancers. Preliminary
preclinical and clinical data suggest that ONA-XR has anticancer
activity by inhibiting progesterone receptor binding to chromatin,
downregulating cancer stem cell mobilization and blocking immune
evasion. ONA-XR is currently being evaluated in three Phase 2
clinical trials and one Phase 1b/2 clinical trial in PR+ breast,
ovarian and endometrial cancers. ONA-XR is an investigational drug
that has not been approved for marketing by any regulatory
authority.
About Context Therapeutics®Context Therapeutics
Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical
company committed to advancing medicines for female cancers. The
Company’s pipeline includes small molecule and bispecific antibody
drug candidates that target cancer signaling pathways. Onapristone
extended release (ONA-XR), a novel, first-in-class potent and
selective progesterone receptor antagonist, is currently in three
Phase 2 clinical trials and one Phase 1b/2 clinical trial in
hormone-driven breast, ovarian, and endometrial cancers. Context is
also developing CTIM-76, a selective Claudin 6 (CLDN6) x CD3
bispecific antibody for CLDN6 positive tumors, currently in
preclinical development. Context is headquartered in
Philadelphia. For more information, please
visit www.contexttherapeutics.com or follow the Company
on Twitter and LinkedIn.
Forward-looking StatementsThis press release
contains “forward-looking statements” that involve substantial
risks and uncertainties for purposes of the safe harbor provided by
the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, included in
this press release regarding strategy, future operations,
prospects, plans and objectives of management, including words such
as "may," "will," "expect," "anticipate," "plan," "intend," and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
forward-looking statements. These include, without limitation,
statements regarding (i) the expectation to report Phase 1b data
for the ELONA trial in the fourth quarter of 2023, (ii) the results
of our clinical trials, (iii) the potential benefits and side
effect profile of our product candidates, (iv) the likelihood data
will support future development, and (v) the likelihood of
obtaining regulatory approval of our product candidates.
Forward-looking statements in this release involve substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by the forward-looking
statements, and we, therefore cannot assure you that our plans,
intentions, expectations or strategies will be attained or
achieved. Other factors that may cause actual results to differ
from those expressed or implied in the forward-looking statements
in this press release are discussed in our filings with
the U.S. Securities and Exchange Commission, including the
section titled “Risk Factors” contained therein. Except as
otherwise required by law, we disclaim any intention or obligation
to update or revise any forward-looking statements, which speak
only as of the date they were made, whether as a result of new
information, future events or circumstances or otherwise.
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
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